Drugs

White House Puts 2015 Opioid Crisis Cost at $500 Billion

A new report from the White House’s Council of Economic Advisers estimates that the ongoing opioid crisis cost the U.S. $504 billion (2.8% of gross domestic product) in 2015 and led to over 33,000 American overdose deaths. Survey data indicate that 2.4 million Americans have an opioid-use disorder. “In assessing the benefits of fiscal and regulatory policies that limit opioid abuse in the United States, it is important to understand the costs associated with the epidemic that policies might mitigate,” the report says.

Last month, president Trump declared the opioid abuse crisis a public health emergency, and briefly mentioned FDA’s role: “The FDA is now requiring drug companies that manufacture prescription opioids to provide more training to prescribers and to help prevent abuse and addiction and has requested that one especially high risk opioid be withdrawn from the market immediately,” the president said (see transcript). He presumably was talking about the agency’s recent decision to extend Risk Evaluation and Mitigation Strategy (REMS) requirements that now apply to extended-release/long-acting (ER/LA) opioid formulations to cover immediate-release (IR) formulations as well (see earlier story).

The high-risk opioid being withdrawn from the market is Endo Pharmaceuticals’ Opana ER (oxymorphone hydrochloride), the benefits of which the agency announced in June may no longer outweigh its risks (see story).

The public health emergency declaration comes on the heels of FDA commissioner Scott Gottlieb’s 10/25 testimony before the House Energy and Commerce Committee that FDA is focusing on three broad areas to help address the opioid crisis — lowering overall exposure to opioid drugs and, in turn, reducing the number of new cases of addiction; enabling more opportunities for those currently addicted to opioid drugs to seek medication-assisted treatment that can help them recover; and helping expedite the development of progressively more effective abuse deterrent formulations of opioid drugs and non-opioid alternatives for treating pain.

After the president’s announcement, Gottlieb released a statement saying the agency is “committed to taking additional steps under the new declaration of a public health emergency to more forcefully confront this immense national tragedy. This includes taking aggressive steps to prevent new addictions and opioid-related deaths, and help those currently addicted regain control and restore them to their communities.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome